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Maraviroc Efficacy for Hepatitis C (MAVERIC)

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ClinicalTrials.gov Identifier: NCT02881762
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Lydia Tang, University of Maryland, Baltimore

Brief Summary:
This is a single-site, longitudinal, open-label, interventional study for evaluating the effect of maraviroc on hepatitis C viral levels in patients infected with both hepatitis C and human immunodeficiency virus (HIV) and taking antiretroviral therapy for HIV.

Condition or disease Intervention/treatment Phase
Hepatitis C Human Immunodeficiency Virus Drug: Maraviroc Phase 4

Detailed Description:
Recently, in-vitro studies (experiments performed in a laboratory, not on a person) have demonstrated that maraviroc, a medication that is used in human immunodeficiency (HIV) therapy, appears to have significant hepatitis C antiviral effect, comparable to sofosbuvir-a potent anti-hepatitis C medication. In this study, the investigators will evaluate the antiviral effect of maraviroc on hepatitis C virus in people infected with both hepatitis C and HIV, and whom have never been treated for hepatitis with direct antiviral agents. Participants will take maraviroc for 4 weeks in addition to their regular HIV antiretrovirals (ART). The investigators will measure the hepatitis C viral load before, during, and after the 4-week maraviroc time.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Anti-Hepatitis C Virus Effect of Maraviroc in Patients Co-infected With Human Immunodeficiency Virus (HIV) and Hepatitis C
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : March 27, 2019
Actual Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Maraviroc

Arm Intervention/treatment
Active Comparator: Immediate start maraviroc
To start maraviroc immediately after randomization.
Drug: Maraviroc
Participants will receive 4 weeks of maraviroc (dosing based on concomitant HIV antiretroviral regimen). Serial measurements of HCV viral load will be obtained before, during, and after maraviroc exposure. Study duration will be approximately 12 to 16 weeks.
Other Name: Selzentry

Active Comparator: Delayed start maraviroc
To start maraviroc 8 weeks after enrollment.
Drug: Maraviroc
Participants will receive 4 weeks of maraviroc (dosing based on concomitant HIV antiretroviral regimen). Serial measurements of HCV viral load will be obtained before, during, and after maraviroc exposure. Study duration will be approximately 12 to 16 weeks.
Other Name: Selzentry




Primary Outcome Measures :
  1. The change in hepatitis C viral load from baseline to end of maraviroc treatment, and end of study (weeks 4, 8, 12 and 16) in people infected with both human immunodeficiency virus and hepatitis C with addition of maraviroc [ Time Frame: 12 to 16 weeks ]
    Maraviroc will be added to existing human immunodeficiency virus anti-retroviral regimens among participants infected with both hepatitis C and human immunodeficiency virus. Hepatitis C viral loads will be measured at the above time points. For participants randomized to immediate start of maraviroc, maraviroc treatment will occur from day 0 to week 4, and the last viral load will be on week 12 (no week 16 tests). Participants randomized to the delayed start group will receive maraviroc treatment from week 8 to week 12, and therefore hepatitis C viral load will be measured at baseline and week 4 of study participation (prior to maraviroc treatment) and the last hepatitis C viral load test will occur at week 16 of the study (4 weeks after completing maraviroc treatment).


Secondary Outcome Measures :
  1. Change in hepatitis C viral loads from baseline to days 2, 3, 5 and 7 of starting maraviroc in people infected with both human immunodeficiency virus and hepatitis C [ Time Frame: 7 days ]
    Maraviroc will be added to existing human immunodeficiency virus anti-retroviral regimens among participants infected with both hepatitis C and human immunodeficiency virus. Serial blood tests for Hepatitis C viral load will be obtained during the first 7 days of maraviroc initiation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years old
  2. Hepatitis C-infected without plans to undergo hepatitis C treatment for duration of the study
  3. Human immunodeficiency virus (HIV) infected
  4. Currently receiving anti-retroviral therapy with HIV viral load <50 IU/ml for ≥ 12 months

    a. One virologic blip ≤ 400 copies/ml permissible within the 12 months

  5. CD4 T cell counts > 100 cells/mm3
  6. Non-cirrhotics and cirrhotics can be included
  7. Willing to sign informed consent

Exclusion Criteria:

  1. Age < 18
  2. Unable to comply with study visits, research study visits, or is planning to relocate during the study.
  3. Have any condition that the investigator considers a contraindication to study participation
  4. Pregnancy or breast feeding
  5. Decompensated liver disease (Child-Pugh C)
  6. Imminent treatment for hepatitis C infection
  7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal
  8. Concomitant use of drugs known to impact or be impacted in terms of pharmacokinetics or drug-drug interactions with either raltegravir, dolutegravir, or maraviroc. This includes:

    • Inducers of UGT1A1 (such as rifampin, phenytoin, phenobarbital rifabutin, St. John's wort)
    • Cytochrome P3A inhibitors (such as ketoconazole, itraconazole, clarithromycin, nefazodone, and telithromycin)
    • Cytochrome P3A inducers (such as rifampin, carbamazepine, phenobarbital and phenytoin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881762


Locations
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United States, Maryland
Institute of Human Virology at the University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
ViiV Healthcare
Investigators
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Principal Investigator: Lyida Tang, MBChB Assistant Professor

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Responsible Party: Lydia Tang, Assistant Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02881762     History of Changes
Other Study ID Numbers: HP-00070324
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lydia Tang, University of Maryland, Baltimore:
hepatitis C virus (HCV)
Maraviroc
Human immunodeficiency virus (HCV)
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Immunologic Deficiency Syndromes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Maraviroc
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
CCR5 Receptor Antagonists